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Abbott Laboratories (ABT)
NYSE:ABT
Itopride Hydrochloride 150 Mg Extended Release Tablets, Itopride Hydrochloride 50 Mg Film Coated Tablets
Functional Dyspepsia
Phase III
Active Not Recruiting
Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia
Nov 24, 2023
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Mebeverine+Simethicone, Mebeverine, Simethicone
Functional Bowel Disorder
Phase III
Completed
Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders
Dec 14, 2021
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Abbott Laboratories (ABT) have in its pipeline
ABT is currently developing the following drugs: Itopride Hydrochloride 150 Mg Extended Release Tablets, Itopride Hydrochloride 50 Mg Film Coated Tablets, Mebeverine+Simethicone, Mebeverine, Simethicone. These drug candidates are in various stages of clinical development as the company works toward FDA approval.